First Human Trial of Stem Cell Transplantation in Complex Arrays for Stroke Patients Using the Intracerebral Microinjection Instrument

医学 微量注射 移植 冲程(发动机) 脑出血 中风恢复 外科 物理医学与康复 内科学 物理疗法 康复 机械工程 工程类 蛛网膜下腔出血
作者
Guang-Zhu Zhang,Miles G. Cunningham,Hong‐Tian Zhang,Yiwu Dai,Ping Zhang,GuangZhi Ge,Beibei Wang,Miaochun Bai,Thomas G. Hazel,Karl Johe,Ruxiang Xu
出处
期刊:Operative Neurosurgery [Lippincott Williams & Wilkins]
卷期号:18 (5): 503-510 被引量:11
标识
DOI:10.1093/ons/opz204
摘要

Abstract BACKGROUND In preclinical studies, the Intracerebral Microinjection Instrument (IMI) has demonstrated the ability to deliver therapeutics within the brain in 3-dimensional arrays from a single overlying penetration while incurring minimal localized trauma. OBJECTIVE To evaluate the safety and performance of the IMI in its first use in humans to deliver stem cells in complex configurations within brain regions affected by ischemic injury. METHODS As part of a phase 1 study, 3 chronically hemiparetic motor stroke patients received intracerebral grafts of the therapeutic stem cell line, NSI-566, using the IMI and its supporting surgical planning software. The patients were 37 to 54 yr old, had ischemic strokes more than 1 yr prior to transplantation, and received Fugl-Meyer motor scale scores of 17-48 at screening. During a single surgical procedure, patients received several neural grafts (42 ± 3) within the peri-infarct region targeted strategically to facilitate neural repair. RESULTS The IMI enabled multiple cellular deposits to be safely placed peripheral to stroke lesions. The procedure was well tolerated, recovery was uneventful, and there occurred no subsequent complications. The IMI performed reliably throughout the procedures without evident targeting errors. One year after transplantation, all 3 subjects displayed significant clinical improvement, and imaging analysis demonstrated occupation of infarct cavities with new tissue without tumor formation. CONCLUSION IMI technology permits unprecedented numbers of injections to be tactically placed in 3-dimensional arrays safely and reliably in human subjects. This advanced methodology can optimize the benefits of novel therapeutics by enabling versatile 3-dimensional intracerebral targeting.
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